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Beckman Coulter Inc. Recall 87738

Description: Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e

Beckman Coulter Inc. Recall 87738 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1670-2021
Event ID87738
Event DescriptionAccess SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia and the country of New Zealand.
Quantity1,034 units
Recall Reasonspecimens collected in transport media may result is false negative results when stored in certain conditions.
Device Classification20210602
Device Code InfoAll Lots
Center Classification Date20210521
Recall Initiation Date20210414
Recalling FirmBeckman Coulter Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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