Reported Jul 31, 2019 · Terminated
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem…
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 BNP Calibrators Ptoduct UsageThe ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 003807400174600038074001746000380740017460003807400174600038074001746044K79318 (23JUL2019) (01)00380740017460(17)190723(10)44K79318, 44K80818 (05SEP2019) (01)00380740017460(17)190905(10)44K80818, 44K82118 (09OCT2019) (01)00380740017460(17)191009(10)44K82118, 44K82618 (15NOV2019) (01)00380740017460(17)191115(10)44K82618, 44K85119 (22JAN2020) (01)00380740017460(17)200122(10)44K85119 2 00380740145255003807401452550038074014525500380740145255List Number 8K2803 - Lot Number (Expiration Date) UDI: 44K79418 (23Jul2019) (01)00380740145255(17)190723(10)44K79418, 44K81018 (5Sep2019) (01)00380740145255(17)190905(10)44K81018, 44K82018 (9Oct2019) (01)00380740145255(17)191009(10)44K82018, 44K85219 (22Jan2020) (01)00380740145255(17)200122(10)44K85219 3 List Number 8K2809, Lot Number 44K84119, Expiration Date 17Dec2019, No UDI - Amount recalled
- 5,483 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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