Reported Apr 10, 2019 · Terminated
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
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 7D6341.
- Lot codes and dates
- Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.
- Amount recalled
- 30 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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