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Terminated

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 diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

FDA Recall Z-2541-2018 · Posted None

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2018-04-02
Product Quantity153

Reason for Recall

The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.

Firm Action

An Urgent Product Correction notification letter dated 4/2/18 was distributed to customers. The letter instructed customers to check the system and confirm it is labeled as shown in the letter. Then complete the attached form, indicating if the system includes a D-Link Brand USB hub, and fax or email back the form to Bio-Rad as soon as possible. If needed, a Bio-Rad Technical Support Representative will contact you shortly to arrange for replacement of the hub.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution inn 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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