Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues
Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a stability issue leading to error codes and out-of-range quality control results, with no reported injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Abbott Laboratories, Inc. is recalling 30 kits of the Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. The recall is due to a stability issue that may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
The affected product is identified by Lot number 99633UN18, with an expiration date of 02JAN19. The UDI is (01)00380740101176(17)190102(10)99633UN18.
Distribution was made nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution included numerous countries across multiple continents. Consumers and healthcare facilities should check their inventory for this specific lot number and contact Abbott Laboratories for instructions on how to proceed.
The recalled product
- Product
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
- Manufacturer
- Abbott Laboratories, Inc
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number 99633UN18
- exp. 02JAN19
- UDI (01)00380740101176(17)190102(10)99633UN18.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Laboratories, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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