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  1. Recalls (Biologics)

2018 Biologics Recalls

Date Notification Brand Name Product Description Reason/Problem Company
September 28, 2018 Recall Notification to Clients with Possible Product On-Hand, Effective 9/28/18 ALL ReGen Series Consignees were instructed to not use the vials, due to reported adverse reactions. Genetech, Inc.
San Diego, CA

Yorba Linda, CA
August 23, 2018 URGENT Drug Recall for Leukotrap RC System with RC2D Filter Product ID: 129-62; 129-63 Haemonetics Corporation is voluntarily recalling 10 lots of their Leukotrap RC System with RC2D Filter (Reorder #129-62 and 129-63). Haemonetics Manufacturing Inc.
Covina, CA
April 16, 2018 Voluntary Medical Device Safety Alert: SPECTRA OPTIA APHERESIS SYSTEM
Reminder to Prime Blood Warmers
Devices Affected: All Spectra Optia Apheresis Systems TerumoBCT has issued a Voluntary Medical Device Safety Alert for two purposes. To remind Spectra Optia system users of this potential safety hazard: If a blood warmer is attached to a Spectra Optia tubing set and the blood warmer is not primed before use, air could be delivered to a patient. AND to reinforce the actions required to mitigate this risk. TerumoBCT
Lakewood, CO
April 6, 2018 URGENT: DXT Relay RECALL/FIELD ACTION - DXT Relay Software Upgrade Affected Products: DXT Relay 2.X (5S9800, 5S9801, 5S9802, 5S9803) Fresenius Kabi USA has initiated a mandatory software update Field Action of the DXT Relay 2.x because of issues identified in the software that cause the software to operate other than expected. Fresenius-Kabi
Lake Zurich, IL
April 5, 2018 Product Application Notice: Acrodose PLus Systems Affected (Reorder Codes): 732-82 and 732-83 On March 28, 2018, Haemonetics informed its customers of an urgent recall for specific lots of the Acrodose Plus Systems; reorder codes (732-82 and 732-83) and advised customers to discontinue use of unused affected lots.

Based on customer requests, Haemonetics is advising on a method to utilize an alternate storage bag if local procedures permit.
Haemonetics Corporation
Braintree, MA
March 29, 2018 Urgent: 4R5725 and 6R5725 Recall/Field Action Alyx Component Collection System
Affected Products Codes: 4R5725 and 6R5725
Fresenius Kabi USA has initiated a mandatory software update Field Action of the Alyx Component Collection System, because of an issue identified when the Alyx instrument is used for the RBC/Plasma procedure, Alyx kit codes 4R5700 and X4R5700. Fresenius-Kabi
Lake Zurich, IL
March 28, 2018 Urgent Medical Device Recall For Acrodose PLus and PL Systems Acrodose PLus and PL Systems (codes 732-82, 732-83, & 732-86) Haemonetics has recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems. Haemonetics Corporation
Braintree, MA
March 22, 2018 Urgent: Recall Notification Prothrombin Complex Concentrate (Human) Batch Numbers: M9560111E, N1260111A , N1360111A CSL Behring is notifying customers of a potential risk of breakage of the glass vials with respect to the three (3) mentioned Kcentra lots, which were distributed until March 2018. There is an increased risk of breakage during transport and handling of the product due to a change in the secondary packaging configuration in January 2018. CSL Behring GmbH
Marburg, Germany


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