Thermo Fisher: Medical Device Recall in 2018 - (Recall #: Z-2137-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

Product Classification:

Class II

Date Initiated: May 4, 2018

Date Posted: June 20, 2018

Recall Number: Z-2137-2018

Event ID: 80068

Reason for Recall:

Product may fail performance testing for S aureus ATCC 43300.

Status: Terminated

Product Quantity: 67 units

Code Information:

Lot: 307200

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated