Official recall record

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Softw

US FDA — Medical Devices · 2025-06-10 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2025-06-10
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 10758750004577
Brand on record: Ortho-Clinical Diagnostics, Inc.
Product category: Medical Device

What the authority reported

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2020-05-11 · US FDA — Medical Devices
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitr

Other recalls from this brand

2025-07-29 · US FDA — Medical Devices
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slid
2025-06-12 · US FDA — Medical Devices
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered
2025-06-10 · US FDA — Medical Devices
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/C

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.