🔍 RecallPedia

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Class I - Dangerous
🏥 Medical Devices Recalled: November 28, 2012 Mindray DS USA, Inc. d.b.a. Mindray North America Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mindray DS USA, Inc. d.b.a. Mindray North America
Reason for Recall:
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

BS-200 Chemistry Analyzer Designed for clinical laboratory use.

Product Codes/Lot Numbers:

Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.

Distribution:

Distributed in: NC, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0977-2013

Related Recalls

Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

Mindray DS USA, Inc. d.b.a. Mindray North America

Class I - Dangerous

Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.

Nov 28, 2012 Diagnostic Equipment Nationwide View Details →

DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

Mindray DS USA, Inc. d.b.a. Mindray North America

Class I - Dangerous

There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.

May 12, 2011 Diagnostic Equipment Nationwide View Details →