ModerateClass IITerminated

FDA Devices recall · Reported May 16, 2018

NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)0643814

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1692-2018.

Q: Where was the recalled product distributed?

Distribution: Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1692-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling…

Recall #: Z-1692-2018
Affected scope: 5275
Initiated: November 2, 2017

Compiled from official public sources by the publisher. · Updated August 2026

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PerkinElmer Life and Analytical Sciences, Wallac, Oy recalled NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: … - a moderate-severity action.

NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: … was recalled by PerkinElmer Life and Analytical Sciences, Wallac, Oy in May 16, 2018. Reason: There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instruc…. Check the official notice for the remedy. Verify recall #Z-1692-2018 with the FDA Devices before acting.

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The recall

PerkinElmer Life and Analytical Sciences, Wallac, Oy issued this moderate-severity FDA Devices recall-There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instruc….

Moderate
severity level: 5K units
affected scope: Class II
classification: May 16, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1692-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1692-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on November 2, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. PerkinElmer Life and Analytical Sciences, Wallac, Oy is listed as the recalling firm, operating out of Turku, N/A. Federal records list the affected scope as 5275.

The documented reason for this recall is: There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials. Distribution data in the federal record shows the product reached: Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

5275

Related Recalls

6 from same agency

Product description

NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

Reason for recall

There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1692-2018
Date reported	May 16, 2018
Date initiated	November 2, 2017
Recalling firm	PerkinElmer Life and Analytical Sciences, Wallac, Oy
Firm location	Turku, N/A
Affected scope	5275
Distribution	Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

5275 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1692-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1692-2018.

Where was the recalled product distributed? ▼

Distribution: Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1692-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 16, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.