Reticcount 349204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903492046), received between Jul 20, 2021 and Jul 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PACKAGING WAS LEAKING AND PRODUCTS LABEL INFORMATION WAS ERASED WITH BD RETIC-COUNT¿. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: (1 OF 2 COMPLAINTS) ON THE OTHER HAND, UPON RECEIPT, WE NOTICED THAT THE PRODUCT WAS LEAKING DESPITE THE PACKAGING PRECAUTIONS. THE PREVIOUS BATCH WAS ALSO LEAKING. MOREOVER, EACH TIME, THE LABEL IS COMPLETELY ERASED. THIS PRODUCT IS LIKELY TO BE CARCINOGENIC (SEE DATA SHEET), AND WITH THIS PROBLEM OF LEAKAGE, WE PUT SOME EVERYWHERE ON THE GLOVES, THE MAT... COULD YOU PLEASE FORWARD OUR REMARKS TO THE COMPETENT SERVICE IN ORDER TO GUARANTEE A BETTER SAFETY OF THE USERS. - WE DID NOT COME INTO CONTACT WITH THE PRODUCT WITHOUT PROTECTIVE EQUIPMENT, WE ALWAYS HANDLED IT WITH GLOVES. HOWEVER, THE BENCH WAS CONTAMINATED AND WE DECONTAMINATED IT WITH ACTIVATED CARBON. CAN YOU CONFIRM THAT THIS PRODUCT IS INDEED CARCINOGENIC?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197522 ↗
• MalfunctionJul 20, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PACKAGING WAS LEAKING AND PRODUCTS LABEL INFORMATION WAS ERASED WITH BD RETIC-COUNT¿. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: (2 OF 2 COMPLAINTS): ON THE OTHER HAND, UPON RECEIPT, WE NOTICED THAT THE PRODUCT WAS LEAKING DESPITE THE PACKAGING PRECAUTIONS. THE PREVIOUS BATCH WAS ALSO LEAKING. MOREOVER, EACH TIME, THE LABEL IS COMPLETELY ERASED. THIS PRODUCT IS LIKELY TO BE CARCINOGENIC, AND WITH THIS PROBLEM OF LEAKAGE, WE PUT SOME EVERYWHERE ON THE GLOVES THE MAT. COULD YOU PLEASE FORWARD OUR REMARKS TO THE COMPETENT SERVICE IN ORDER TO GUARANTEE A BETTER SAFETY OF THE USERS. WE DID NOT COME INTO CONTACT WITH THE PRODUCT WITHOUT PROTECTIVE EQUIPMENT, WE ALWAYS HANDLED IT WITH GLOVES. HOWEVER, THE BENCH WAS CONTAMINATED AND WE DECONTAMINATED IT WITH ACTIVATED CARBON. CAN YOU CONFIRM THAT THIS PRODUCT IS INDEED CARCINOGENIC?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197520 ↗