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BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection ...

FDA Device Recall #Z-1416-2021 — Class II — March 24, 2021

Recall Summary

Recall Number Z-1416-2021
Classification Class II — Moderate risk
Date Initiated March 24, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Co.
Location Sparks, MD
Product Type Devices
Quantity 21,529 Kits

Product Description

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

Reason for Recall

BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System

Distribution Pattern

US Nationwide

Lot / Code Information

Lot Numbers/Exp. Date: Lot Number Expiration Date K20-347 1/23/2021 K20-348 1/23/2021 K20-352 1/24/2021 K20-353 1/24/2021 K20-354 1/24/2021 K20-355 1/25/2021 K20-357 1/25/2021 K20-356 1/25/2021 K20-358 1/26/2021 K20-366 1/28/2021 K20-367 1/29/2021 K20-373 1/30/2021 K20-376 1/31/2021 K20-377 1/31/2021 K20-382 2/1/2021 K20-378 2/2/2021 K20-379 2/2/2021 K20-380 2/3/2021 K20-381 2/3/2021 K20-385 2/5/2021 K20-386 2/6/2021 K20-538 3/1/2021 K20-576 3/20/2021 K20-577 3/20/2021 K20-578 3/20/2021 K20-565 3/21/2021 K20-566 3/21/2021 K20-567 3/21/2021 K20-568 3/21/2021 K20-515 3/24/2021 K20-516 3/24/2021 K20-511 3/27/2021 K20-512 3/27/2021 K20-517 3/28/2021 K20-545 3/28/2021 K20-546 3/28/2021 K20-547 3/28/2021 K20-548 3/28/2021 K20-549 3/28/2021 K20-536 3/29/2021 K20-537 3/29/2021 K20-518 4/1/2021 K20-522 4/1/2021 K20-520 4/2/2021 K20-521 4/2/2021 K20-523 4/2/2021 K20-525 4/2/2021 K20-528 4/3/2021 K20-529 4/3/2021 K20-530 4/3/2021 K20-570 4/3/2021 K20-514 4/4/2021 K20-560 4/4/2021 K20-519 4/5/2021 K20-561 4/5/2021 K20-562 4/5/2021 K20-629 4/5/2021 K20-630 4/5/2021 K20-550 4/6/2021 K20-551 4/6/2021 K20-552 4/6/2021 K20-553 4/7/2021 K20-533 4/8/2021 K20-524 4/9/2021 K20-526 4/9/2021 K20-531 4/9/2021 K20-532 4/9/2021 K20-539 4/10/2021 K20-540 4/10/2021 K20-569 4/11/2021 K20-571 4/11/2021 K20-541 4/12/2021 K20-542 4/12/2021 K20-543 4/12/2021 K20-554 4/12/2021 K20-555 4/12/2021 K20-556 4/12/2021 K20-579 4/12/2021 K20-580 4/12/2021 K20-527 4/13/2021 K20-563 4/13/2021 K20-564 4/13/2021 K20-544 4/14/2021 K20-534 4/16/2021 K20-572 4/16/2021 K20-573 4/16/2021 K20-557 4/17/2021 K20-558 4/17/2021 K20-559 4/17/2021 K20-513 4/18/2021 K20-535 4/20/2021 K20-581 4/21/2021 K20-582 4/21/2021 K20-594 4/21/2021 K20-603 4/21/2021 K20-587 4/22/2021 K20-588 4/22/2021 K20-589 4/22/2021 K20-640 4/22/2021 K20-641 4/22/2021 K20-642 4/22/2021 K20-574 4/23/2021 K20-575 4/24/2021 K20-583 4/25/2021 K20-584 4/25/2021 K20-585 4/25/2021 K20-586 4/25/2021 K20-596 4/26/2021 K20-592 4/27/2021 K20-590 4/28/2021 K20-591 4/28/2021 K20-622 4/29/2021 K20-623 4/29/2021 K20-593 4/30/2021 K20-597 5/1/2021 K20-598 5/1/2021 K20-609 5/1/2021 K20-610 5/1/2021 K20-611 5/1/2021 K20-612 5/1/2021 K20-618 5/1/2021 K20-619 5/1/2021 K20-599 5/2/2021 K20-604 5/2/2021 K20-605 5/2/2021 K20-627 5/2/2021 K20-628 5/2/2021 K20-602 5/3/2021 K20-607 5/3/2021 K20-608 5/3/2021 K20-601 5/4/2021 K20-606 5/4/2021 K20-595 5/5/2021 K20-613 5/6/2021 K20-614 5/6/2021 K20-624 5/7/2021 K20-625 5/7/2021 K20-615 5/9/2021 K20-616 5/9/2021 K20-617 5/9/2021 K20-621 5/9/2021 K20-600 5/10/2021 K20-620 5/11/2021 K20-632 5/11/2021 K20-633 5/11/2021 K20-626 5/12/2021 K20-631 5/13/2021 K20-638 5/13/2021 K20-639 5/13/2021 K20-634 5/14/2021 K20-635 5/14/2021 K20-643 5/14/2021 K20-636 5/16/2021 K20-637 5/17/2021 UDI: 382904442132

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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