PerkinElmer AutoDELFIA IRT Kit Recall: Missing Quality Control Certificate
PerkinElmer recalls AutoDELFIA Neonatal IRT kits with missing Quality Control Certificate that may delay test results. Affected kits have specific UDI and expiration dates.
Lower-risk recall
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
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What happened, in plain English
PerkinElmer is recalling certain AutoDELFIA Neonatal IRT kits because their Quality Control Certificate is missing required information. This could delay reporting test results for blood samples. The recall affects kits with specific UDI numbers and expiration dates. Read more at govinfonow.com/recall/72947-perkinelmer-autodelfia-irt-kit-recall-missing-quality-control-certificate.
Source Summary by GovInfoNow · govinfonow.com/recall/72947-perkinelmer-autodelfia-irt-kit-recall-missing-quality-control-certificate · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1220-2018
Cite this page
“PerkinElmer AutoDELFIA IRT Kit Recall: Missing Quality Control Certificate.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72947-perkinelmer-autodelfia-irt-kit-recall-missing-quality-control-certificate. Based on FDA recall #Z-1220-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2018%22&limit=1).
Why it’s dangerous
The missing Quality Control Certificate means the kit cannot properly assess test results. This could delay reporting immunoreactive trypsin(ogen) levels in blood samples, but does not cause immediate harm.
Who’s affected
Healthcare providers using the AutoDELFIA Neonatal IRT kits for blood tests are most likely affected. The recall targets specific kits with particular UDI and expiration dates.
How to tell if you have this one
Check for the UDI number (01)06438147298716(17)190430(10)656479 and expiration date of 2019-04-30 on the kit packaging. The product number is B005-212 and batch number is 1065647901.
- Brand
PerkinEl:mer- Product
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human- Category
Medical device
What to do — step by step
Check Kit Details
Verify the UDI number (01)06438147298716(17)190430(10)656479 and expiration date of 2019-04-30 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in Connecticut and Texas.
FDA distribution: “Distributed to CT and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Texas.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this kit?
The recall is for potential delays in test results, not a risk of injury. The hazard does not involve physical harm.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1220-2018 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1220-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.