Drug recall

Reagent Red Blood Cells

FDA recall event 76170 · Class III · Ortho Clinical Diagnostics Inc

Key facts

Event ID 76170
Recall numbers B-0279-2017
Recalling firm Ortho Clinical Diagnostics Inc
Product type Biologics
Products Reagent Red Blood Cells
Classification Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Ortho reagent products, not meeting product specifications, were distributed.
Initiation date Oct 31, 2016
Report date Jan 25, 2017
Termination date Jan 17, 2017
City Raritan
State NJ
Country United States
FEI number 2250051

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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