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Cellex Recall 88206

Description: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

Cellex Recall 88206 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2452-2021
Event ID88206
Event DescriptionCellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, TX, and WI.
QuantityApproximately 44,821 kits
Recall ReasonThe kit does not have an emergency use authorization (EUA).
Device Classification20210922
Device Code InfoAll lot numbers
Center Classification Date20210913
Recall Initiation Date20210301
Recalling FirmCellex
Initial Notification Telephone
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