ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitat
FDA device recall Z-2613-2017 · posted 2017-05-03 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
- Action taken
- Abbott sent an Product Correction ( Immediate Action Required ) letter dated April 18, 2017, to all affected customers (with a response form) shipped via FedEx. Customers were instructed to discontinue use of the Potassium EDTA specimen tube type with the assay. All impacted US consignees were requested to return a customer reply form acknowledging that all the necessary actions, letter, were understood and completed. All impacted distributors were required to provide signed attestation ensuring that all their affected customers were sent the product correction letter informing them of this issue. Remaining inventory, at the firm's distribution centers, will have labeling corrected by inserting a kit stuffer informing customers that Potassium EDTA specimen tube type should not be used and providing customers will the recommend specimen types. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1(877) - 4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CDZ
- Quantity affected
- 7981 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHI
- Date initiated
- 2017-04-18
- Date posted
- 2017-05-03
- Date terminated
- 2019-06-03
- Location
- Abbott Park, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818) | Biokit, S.A. | 2007-01-23 |