Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

VITROS Immunodiagnostic Products TSH Reagent Pack

FDA Recall Z-1322-2018 · Posted 2018-04-10

Recalling FirmClinical Diagnostic Systems
Recall StatusTerminated
Product CodeJLW
Date Initiated2018-01-11
Date Terminated2020-09-08
Product QuantityLot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)

Reason for Recall

VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.

Firm Action

Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMOrtho-Clinical Diagnostics · 2008-12-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑