Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 28, 2016
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Unique Device Identifier (UDI) is missing from outer kit box label.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
PerkinElmer Health Sciences, Inc. recalled EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative… - a low-severity action.
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative… was recalled by PerkinElmer Health Sciences, Inc. in December 28, 2016. Reason: Unique Device Identifier (UDI) is missing from outer kit box label.. Check the official notice for the remedy. Verify recall #Z-0897-2017 with the FDA Devices before acting.
The recall
PerkinElmer Health Sciences, Inc. issued this low-severity FDA Devices recall-Unique Device Identifier (UDI) is missing from outer kit box label..
- Low
- severity level
- Class III
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0897-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0897-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on December 5, 2016. It is classified under Low severity (Class III), with a current status of Terminated. PerkinElmer Health Sciences, Inc. is listed as the recalling firm, operating out of N/A. Federal records list the affected scope as 73 kits.
The documented reason for this recall is: Unique Device Identifier (UDI) is missing from outer kit box label. Distribution data in the federal record shows the product reached: MA, AK. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
73 kits
Related Recalls
6
3 from same agency
Product description
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Reason for recall
Unique Device Identifier (UDI) is missing from outer kit box label.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0897-2017 |
| Date reported | December 28, 2016 |
| Date initiated | December 5, 2016 |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Firm location | N/A |
| Affected scope | 73 kits |
| Distribution | MA, AK |
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-0897-2017) 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? ▼
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U. Recalled by PerkinElmer Health Sciences, Inc.. Units affected: 73 kits.
Why was this product recalled? ▼
Unique Device Identifier (UDI) is missing from outer kit box label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Low. Recall number: Z-0897-2017.
Where was the recalled product distributed? ▼
Distribution: MA, AK.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0897-2017) 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 December 28, 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.