Reported Apr 10, 2019 · Terminated
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Abbott Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313
Is this the product you have?
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 Lot number 87697UN18, exp. 22OCT18 2 00380740012878UDI (01)00380740012878 (17)181022(10)87697UN18 3 00380740012878Lot number 99632UN18, exp. 12NOV18, UDI (01)00380740012878 (17)181112(10)99632UN18 4 00380740012878and Lot 24358UN18, exp. 05DEC18, UDI (01)00380740012878 (17)181205(10)24358UN18. - Amount recalled
- 6,187 kits kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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