Agency classClass IIOur severity:High FDA (Devices)·Z-1320-2018·Announced 2018-04-18

Mindray Hematology Diluent M-30D Recalled for Elevated Platelet Background Counts

Mindray is recalling specific lots of M-30D diluent used with BC-3200 and BC-3600 analyzers because they may cause the system to produce an elevated platelet background count.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential diagnostic error (elevated platelet background count) in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling certain lots of Hematology Diluent M-30D. This product is an azide-free, filtered isotonic solution used for counting and sizing blood cells with the Mindray BC-3200 and BC-3600 Hematology Analyzers. The recall involves 4,838 units distributed in the United States, including Puerto Rico, and in the states of California, Michigan, North Carolina, Texas, and Washington.

The recall was initiated because the affected diluent lots may cause the hematology analyzer system to produce an elevated platelet background count. This issue is associated with specific part numbers and lot numbers for both 2 x 5.5L and 20L container sizes.

Healthcare facilities and users of the affected analyzers should stop using the identified lots of M-30D diluent. Mindray is the recalling firm responsible for managing the recall and providing further instructions to affected customers.

The recalled product

Product: Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for…
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Category: Medical Device — Hematology Analyzer Consumable
Hazard: diagnostic-error
Affected units: 4,838

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

(1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906
2017041207
2017042707
2017041104
2016122301
2016112901
2016060401
2016052701
2016052101
2016050301
(2)105-005406-00 (20L container) Lot Numbers: 2017041104
2016121901
2016051801

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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