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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84497

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 09, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mindray DS USA, Inc. dba Mindray North America

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

Z-0920-2020
Recall number
Z-0920-2020
Initiated
December 09, 2019
Classification
Class II
Status
Terminated
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

Code information

Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011

Distribution pattern

The products were distributed to the following US states: MI and TX.

device · product 2 of 2

ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

Z-0921-2020
Recall number
Z-0921-2020
Initiated
December 09, 2019
Classification
Class II
Status
Terminated
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

Code information

Serial Numbers W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T

Distribution pattern

The products were distributed to the following US states: MI and TX.