Recall Z-1707-2015— ORTHO-CLINICAL DIAGNOSTICS
Class III · Terminated
Class III FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2015-05-06, terminated 2017-09-13. It names one FDA 510(k) clearance: K964310. Product: VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.. Reason: The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels..
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-05-06
- Terminated
- 2017-09-13
- Firm location
- Bridgend, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-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 Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Reason for recall
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.