Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

FDA Recall #Z-1229-2024 — Class II — January 26, 2024

Recall #Z-1229-2024 Date: January 26, 2024 Classification: Class II Status: Ongoing

Product Description

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

Reason for Recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Recalling Firm

Ortho-Clinical Diagnostics, Inc. — Rochester, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

9 US; 66 OUS

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Code Information

VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers: US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348 OUS: J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

Browse All Device Recalls Device Recall Stats Device Safety Home
Back to All Device Recalls