Reported Jul 22, 2015 · Terminated
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD…
BD Biosciences, Systems & Reagents
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: BD Biosciences, Systems & Reagents · 2350 Qume Dr · San Jose, CA · 95131-1812
Is this the product you have?
- BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
- Lot codes and dates
1,769 of 1,769 codes
Material No. Serial No. 343202 E0565343202 E3190338960 V96100212338962 V96300187338962 V96300189342975 E97500564338962 V96300231342975 E9750070033300472 H47200110338962 V96300567338960 V96100817338960 V96100911338960 V96100913338962 V96300761338960 V96101255648063 H06300007647793 H79300005343276 E4731337175 V07300249647785 H64778500001647793 H64779300011338960 V33896101603338962 V33896301405340128 W91100061340128 W91100104343202 E0035343202 E0108343202 E0692343202 E0849343202 E3313343202 E3355343023 E0722343023 E1312343023 E3108654899 V96101131340469 P46900047644655 00-00059-00340551 H47100064644655 00-00068-00340469 P46900070341360 P22300058342975 E97500699340469 P46900093644655 00-00065-00643695 P69500019340551 H47100133643178 P17800016643695 P69500029643695 P69500031338960 V96100758340551 H47100171340551 H47100180340551 H47100193340551 H47100197643182 P18200019341360 P0324644655 00-00027-00643695 P69500082643695 P69500093338960 V96101018
- Amount recalled
- 2188 units
Where it was sold
- Nationwide
Why it was recalled
Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new BD Biosciences, Systems & Reagents recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.