CLASS II ONGOING Device recall · Reported 5 Jan 2022 · FDA Enforcement Report
Vidas Sars-cov-2 IgG recalled by bioMerieux
bioMerieux is recalling Vidas Sars-cov-2 IgG, distributed nationwide in the US. The recall was initiated on 22 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0439-2022
- FDA event ID
- 88797
- Recalling firm
- bioMerieux, Durham, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Sep 2021
- FDA classified
- 28 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Sep 2021 | Recall initiated by company | |
| 28 Dec 2021 | Classified by FDA | +97 days |
| 5 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Product as listed by the FDA
VIDAS SARS-COV-2 IgG, Ref 423834-01
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Which lots are affected?
UDI 03573026620745, Lot #: 1008671430, 1008763910
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 88797This product is part of a recall event; the main page for the event is Vidas RUB IgG (RBG) recalled by bioMerieux.
More recalls from bioMerieux
All 476| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux | Biomerieux | Other | MO |
| Device | CLASS II | Vitek-negative Susceptibility Cards Containing o Polymyxin recalled | Biomerieux | Sterility | Nationwide |
| Device | CLASS II | Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux | bioMerieux | Sterility | NC |
| Device | CLASS I | Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled | Biomerieux | Other | MO |
| Device | CLASS II | Myla comprises Ast Filters in conjunction with Vitek MS recalled | Biomerieux | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |