Reported Oct 17, 2018 · Terminated
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090,…
Becton Dickinson & Co.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
- Lot codes and dates
- Serial Nos.72
646 of 646 codes
FP0749139335141372BD0507BD0508FP0826138739156312BD0513FP0060R159337159339159348FP0705RFPGS-RSBD0089FPGS-RSBD0098FP0804148277FP0284RBD0509BD0511BD0512FP0549CFP0009RFP0013RFP0065RFP0067RFP0172RFP0220RFP0345FP0345RFP0446FP0446RFP0447FP0447RFP0448RFP0494FP0723133215133219128928127632128051FP0049RFP0124R128045128061128914128924128936145182FPGS-RS143333FPGS-RS143339FPGS-RS143346FPGS-RS143347FPGS-RS143352FPGS-RS143358FPGS-RS143359FPGS-RS143360FPGSRS143363
415 of 415 codes
RS161664RSBD0072FP0292RFP0514R144532144840144859145209FPGS-RS142647FPGS-RS142689FPGS-RS143013FPGS-RS143021FPGS-RS143379FPGS-RS143381FP0298RFP0299RFP0465R141635FPGSRS143971FPGSRS143990FPGSRS143994152316152317153937155423155430155441FPGSRS141843FPGSRS141847FPGSRS141858FPGSRS141883FPGSRS141901FPGSRS143349FPGSRS143976FPGSRS144003FPGSRS152315FPGS-RS159945FPGS-RSBD0321FPGS-RSBD0362FP00301R143357143361143375143380143969143972144017148283BD0357FPGSRS142662FPGSRS142669FPGSRS142671FPGSRS142680FPGSRS142693FPGSRS142996FPGSRS143001FPGSRS143003FPGSRS143009FPGSRS143010FPGSRS143011
- Serial Nos.
- Amount recalled
- 1063
Where it was sold
- Nationwide
Why it was recalled
The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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