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.
Reported: January 30, 2013 Initiated: December 12, 2012 #Z-0698-2013
Product Description
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.
Reason for Recall
The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 28,600 total
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: 28,600 total.
Why was this product recalled? ▼
The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2013. Severity: Moderate. Recall number: Z-0698-2013.
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