Abbott Vitamin D Reagent Kit Recalled for Inaccurate Test Results
Abbott Laboratories is recalling ARCHITECT 25-OH Vitamin D Reagent Kits because they may produce falsely elevated or depressed results when used with specific Reaction Vessel lots.
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 involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, but the potential for inaccurate results poses a significant risk to patient care.
Plain-English summary
Abbott Laboratories is recalling the ARCHITECT 25-OH Vitamin D Reagent Kit, an in vitro diagnostic product. The recall involves 28,600 total units distributed worldwide, including the United States and numerous international markets. The affected product includes specific lot numbers and expiration dates, as well as specific ARCHITECT Reaction Vessel box lot numbers.
The recall is being conducted because the assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels. This inaccuracy could lead to incorrect clinical interpretations of Vitamin D levels.
Healthcare facilities and laboratories that have received these specific product lots should stop using them and contact Abbott Laboratories for instructions on how to return the product. Consumers should not use these kits for home testing, as they are intended for professional in vitro diagnostic use.
The recalled product
- Product
- Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 28,600
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)
- ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52
- lot numbers 02412C000
- exp. 12/26/2012
- 02512C000
- 02012G000
- exp. 7/16/2013
- 01612G000
- exp. 7/17/13
- 00912G000
- exp. 7/10/13
- 02512I000
- exp. 10/8/2013
- 02612I000
- 03512I000
- exp. 10/10/2013
- 03712I000
- exp. 10/10/13
- when used with ARCHITECT Reaction Vessel (RV) list 7C15-01
- box lot numbers (bag lot numbers): 19320P100 (6F9891501)
- 19344P100 (4N5891091)
Distribution
Distributed nationwide across the United States.
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