The Recall Desk
HighFDA (Devices)·Z-1629-2018·Announced 2018-05-16

Abbott ARCHITECT DHEA-S Reagent Recalled for False Infant Results

Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm through inaccurate diagnostic results for a vulnerable population (infants), which fits the criteria for a High severity score where injury has not yet been reported.

Plain-English summary

Abbott Gmbh & Co. KG is recalling 10,153 units of ARCHITECT DHEA-S Reagent. This product is a chemiluminescent microparticle immunoassay used for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

The recall was initiated because falsely elevated results may be obtained when using the assay with samples from infants up to 60 days old. The affected lots were distributed worldwide to numerous countries and to specific U.S. states, including Alabama, Arizona, California, and others.

Healthcare facilities and laboratories should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. Users should stop using the affected reagent for testing infant samples up to 60 days old to prevent inaccurate diagnostic results.

The recalled product

Product
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Manufacturer
Abbott Gmbh & Co. KG
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
10,153

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 (20)

  • List No. 8K2-20 with the following Lot No.
  • Exp. Date
  • UDI: a. Lot No. 01316K000
  • Exp. Date 04FEB2018
  • UDI (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720
  • b. Lot No. 01217A000
  • Exp. Date 13APR2018
  • UDI (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720
  • c. Lot No. 02217D000
  • Exp. Date 24JUN2018
  • UDI (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720
  • d. Lot No. 04117H000
  • Exp. Date 25NOV2018
  • UDI (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720
  • List No. 8K27-25 with the following Lot No.
  • UDI: a. Lot No. 01216K000
  • UDI (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725
  • b. Lot No. 01117A000
  • UDI (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725
  • c. Lot No. 02217C000

Distribution

Distributed in 31 states:

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