FDA Device recall Z-2078-2019
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the q…
- FDA Device
- Class III
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class III recall of ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the q… by Abbott Laboratories, citing presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2078-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-05-24 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
ARCHITECT BNP Calibrators Ptoduct Usage: The 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.
Reason
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Identifiers
| code_info | a. List Number 8K2802 - Lot Number (Expiration Date) UDI: 44K79318 (23JUL2019) (01)00380740017460(17)190723(10)44K7931…a. List Number 8K2802 - Lot Number (Expiration Date) UDI: 44K79318 (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; b. List 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; c. List Number 8K2809, Lot Number 44K84119, Expiration Date 17Dec2019, No UDI |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2078-2019%22
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