PlainRecordsFDA · Medical device recall
VITROS Anti-SARS-CoV-2 Total Reagent… and 1 more product
- Date
- Aug. 19, 2020
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ortho Clinical Diagnostics
- Reason
- The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
- Distribution pattern
- Worldwide distribution - US Nationwide distribution.
2 products in this recall
VITROS Anti-SARS-CoV-2 Total Reagent…
- Product
- VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
- Quantity
- 47,271 sales units
- Codes and lots
- Lots 0010-0037
- Recall started
- July 17, 2020
- Device type
- Reagent, Coronavirus Serological
- Root cause (FDA)
- Process control
- What the company told customers
- On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete and submit the enclosed Request for Credit Form, including the pack information, to receive credit for an affected pack. " Complete the Confirmation of Receipt form no later than July 28, 2020. " Post this notification by each system that processes an affected lot. " Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
- Recall number
- Z-2770-2020
VITROS Anti-SARS-CoV-2 IgG Reagent Pack…
- Product
- VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
- Quantity
- 2349 sales units
- Codes and lots
- Lots 0010 - 0013
- Recall started
- July 17, 2020
- Device type
- Reagent, Coronavirus Serological
- Root cause (FDA)
- Process control
- What the company told customers
- On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete and submit the enclosed Request for Credit Form, including the pack information, to receive credit for an affected pack. " Complete the Confirmation of Receipt form no later than July 28, 2020. " Post this notification by each system that processes an affected lot. " Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
- Recall number
- Z-2771-2020
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2770-2020, Z-2771-2020. The agency record governs; check it and the company before acting.