Recall Z-2357-2023— ORTHO-CLINICAL DIAGNOSTICS
Class II · Ongoing
Class II FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2023-06-05. It names 2 FDA 510(k) clearances: K062838, K992366. Product: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack. Reason: Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results..
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-05
- Firm location
- Bridgend, N/A, United Kingdom
510(k) clearances named in this recall
2 on FDA's record- K062838 — VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
- K992366 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reason for recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.