Z-0428-2022Class II

Vidas B.r.a.h.m.s. Procalcitonin Pct, Ref 30450-01

Name: Z-0428-2022 Vidas B.r.a.h.m.s. Procalcitonin Pct, Ref 30450-01
Creator: bioMerieux, Inc.
Published: 2021-09-22
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-09-22 / Open, Classified / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 on 2021-09-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0428-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-22
Posted: 2021-12-28
Recalling firm: bioMerieux, Inc.
Product: Vidas B.r.a.h.m.s. Procalcitonin Pct, Ref 30450-01
Product code: PRI Procalcitonin Assay
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to [email protected] or Fax to: (919) 620-3306 to confirm receipt of this notice.
Quantity in commerce: 28430
Distribution: US Nationwide distribution.
Product codes and lots: UDI 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0428-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0424-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0425-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0426-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0427-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0428-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0429-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0430-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0431-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0432-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0433-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0434-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0435-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0436-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0437-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0438-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28
Z-0439-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-28

Product code PRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)