FDA Device Recalls

Class IIOngoing

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

Ortho-Clinical Diagnostics, INc.

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

December 19, 2024 · DeviceView details →

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

8MM,LONG TIP FORCEPS,IS4000 REF 471048

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

BD PCR Cartridges used with MAX System. Model Number: 437519

KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

8MM,CADIERE FORCEPS,IS4000 REF 471049

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172