The Recall Desk
ModerateFDA (Devices)·Z-1075-2019·Announced 2019-04-10

Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits 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 without reporting any patient injuries, illnesses, or deaths. 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 6,187 kits of the Abbott ARCHITECT Creatine Kinase, IVD (REF 7D63-21). The recall affects three specific lots: 87697UN18 (exp. 22OCT18), 99632UN18 (exp. 12NOV18), and 24358UN18 (exp. 05DEC18).

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. This issue may affect the reliability of test results.

Distribution was made nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution included numerous countries across multiple continents. Users should check their inventory for the affected lot numbers and expiration dates listed above.

The recalled product

Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
6,187

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 (9)

  • Lot number 87697UN18
  • exp. 22OCT18
  • UDI (01)00380740012878 (17)181022(10)87697UN18
  • Lot number 99632UN18
  • exp. 12NOV18
  • UDI (01)00380740012878 (17)181112(10)99632UN18
  • and Lot 24358UN18
  • exp. 05DEC18
  • UDI (01)00380740012878 (17)181205(10)24358UN18.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Abbott Laboratories, Inc

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Same hazard · stability issue

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