The Recall Desk
ModerateFDA (Devices)·Z-2541-2018·Announced 2018-08-01

Bio-Rad PR4100 Microplate Reader Recalled for Power Supply Connector Risk

Bio-Rad is recalling 153 PR4100 Microplate Readers because the power supply connector can fit incompatible components, risking irreparable damage to the system.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves equipment damage (irreparable damage to the system) rather than direct physical injury to patients or users, and no injuries or illnesses are reported in the source text.

Plain-English summary

Bio-Rad Laboratories Inc is recalling 153 units of the PR4100 Microplate Reader US, Catalog Number 45591587. The product is a 96-well absorbance reader intended for in vitro diagnostic analysis of samples from the human body.

The recall was initiated because the connector of the power supply was capable of fitting other components provided with the system. The voltage output of the reader power supply is incompatible with these other components. If incorrectly connected, this incompatibility could result in irreparable damage to the system.

The affected units were distributed nationwide in the United States, including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, and Puerto Rico. Users should check their serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

Product
PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagn
Affected units
153

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 (20)

  • UDI: 00847865014151 Serial Numbers: 140600072
  • 160900991
  • 161001953
  • 1112001938
  • 1112001941
  • 1112004075
  • 1112004079
  • 1112004083
  • 1112004084
  • 1112004086
  • 1112004088
  • 1112004093
  • 1201003822
  • 1201003826
  • 1201003827
  • 1207001007
  • 1207001015
  • 1207001017
  • 1207001018
  • 1208001583

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically: