R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2

FDA device recall Z-0999-2023 · posted 2023-01-19 · Terminated

Recall details

Recalling firm

R & D Systems, Inc.

Reason for recall

For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.

Action taken

The recalling firm issued letters to their OEM/own-label distributor (OLD) customers on 11/7/2022 via email. The letter informed the OEM/OLD of the issue, requested they inspect the Normal Level control for signs of hemolysis or deterioration, and to discard the tubes if hemolysis or deterioration are noted. They are to sign and return the Acknowledgement and Receipt form via email by 12/2/2022. The letter informs the OEM/OLD that a new lot of CBC-3D Normal Level Hematology Control will be available 1/9/2023. The letter did not request them to notify their customers. Updated OEM/OLD letters were issued 11/14/2022 which changed the acknowledgement form to indicate the OEM/OLD has initiated a recall for the product and is notifying their customers. The consignee letters for the recalling firm's customers were issued 11/10/2022 via email. Distributor consignees who have the product drop-shipped to their end users are notifying their own end users. The letter explains the issue, and instructs them to inspect the Normal Level control for signs of hemolysis or deterioration. If signs of hemolysis or deterioration were noted, the tube is to be discarded. An Acknowledgement and Receipt form was enclosed for return to the firm by 11/22/2022 via email. The letter informs the consignee that a new lot of CBC-3D Normal Level Hematology Control will be available 1/9/2023. Also attached to the letter is a Generic Customer Letter to be sent to the distributor's end user customer along with a Customer Medical Device Important Product Notice Return Form. The Generic Customer Letter is to be sent with a cover letter from the distributor partner. On 11/21/2022, the recalling firm issued an email to one customer to notify them that catalog number 3D502 was not impacted by the recall, as it had been listed on the notification issued on 11/10/2022.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JPK

Quantity affected

8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes

Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IA, KY, LA, MA, MO, NC, NJ, NY, OH, TX and Puerto Rico. The countries of Brazil, China, Costa Rica, Czech Republic, Fra

Date initiated

2022-11-07

Date posted

2023-01-19

Date terminated

2026-05-26

Location

Minneapolis, MN

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