Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 23, 2016
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Sekisui Diagnostics P.e.i. Inc. recalled Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catal… - a moderate-severity action.
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catal… was recalled by Sekisui Diagnostics P.e.i. Inc. in March 23, 2016. Reason: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under r…. Check the official notice for the remedy. Verify recall #Z-1171-2016 with the FDA Devices before acting.
The recall
Sekisui Diagnostics P.e.i. Inc. issued this moderate-severity FDA Devices recall-Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under r….
- Moderate
- severity level
- Class II
- classification
- March 23, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1171-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1171-2016) was formally reported on March 23, 2016, with the manufacturer initiating the action on January 22, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Sekisui Diagnostics P.e.i. Inc. is listed as the recalling firm, operating out of Charlottetown. Federal records list the affected scope as 14,407 kits..
The documented reason for this recall is: Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.. 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, 3 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
14,407 kits.
Related Recalls
6
3 from same agency
Product description
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Reason for recall
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1171-2016 |
| Date reported | March 23, 2016 |
| Date initiated | January 22, 2016 |
| Recalling firm | Sekisui Diagnostics P.e.i. Inc. |
| Firm location | Charlottetown |
| Affected scope | 14,407 kits. |
| Distribution | Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1171-2016) 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? ▼
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.. Recalled by Sekisui Diagnostics P.e.i. Inc.. Units affected: 14,407 kits..
Why was this product recalled? ▼
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1171-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1171-2016) 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.
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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 March 23, 2016. 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 July 2026.