Reported May 22, 2019 · Terminated
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i…
Abbott Laboratories
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL · 60064-3502
Is this the product you have?
- ARCHITECT
- HbA1C Calibrators - Product UsageThe ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood
- Lot codes and dates
LN 4P72-01Lot 902920500
- Amount recalled
- 1 unit
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Devices were delivered without the required dry ice.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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