Published: 23 July 2020
Updated 3 September 2020

Safety Information

Alert

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results 

Update Information

03 September 2020

Smiths BioMed is recalling two batches of the Yes! Cassette Pregnancy Test kits. The recalled batches have higher than expected reports of false positives.

Smith BioMed will issue a recall notice to users of these test kits and arrange for replacement batches to be distributed.

Affected batch numbers and expiry dates
  •  Batch: HCG19110040, exp 2022-11
  •  Batch HCG19120028, exp 2022-12
These are supplied in kits of 40 tests, 20 kits per carton.


If you require any information about this recall action, please contact Smiths BioMed on:

This recall does not apply to other batches. Medsafe encourages healthcare professionals to continue using batches not affected by this recall, and to continue reporting if there are any issues with other batches.

Medsafe will continue to monitor this issue and will produce updated advice for health care professionals as necessary.

Original Communication

24 July 2020

Medsafe has received several reports from clinicians, DHBs, clinics and community providers about the Yes! Cassette Pregnancy Test Kits (also known as the Smith BioMed Rapid Pregnancy Test), shown in Figure 1 below. The reports describe false positive test results and inconclusive results. These present as faint lines.

Medsafe is asking health care professionals to report any issues experienced with these test kits, to assist with our decision making.

Products affected
Additional information
Regulator actions
Reporting

Products affected

Product name Sponsor
Yes! Cassette Pregnancy Test Kit

All Batch numbers:
Smith BioMed New Zealand

Additional information

These tests are used as an early detection test for pregnancy. The test is accurate if used 7 days after the next period is due. Hormone levels in women vary and some women may not have detectable levels of hormone on the first day they test for it.

Yes! Cassette Pregnancy Test Kit information leaflet

PHARMAC funds this pregnancy test kit. However, on the Pharmaceutical Schedule, the test kit is called the Smith BioMed Rapid Pregnancy Test (2544873).

Figure 1: Image of the test kit box (a) and test kit (b)

(a)  YES Pregnancy Test Kit (b)  YES Pregnancy Test Kit

Regulator actions

Medsafe will continue to monitor this issue and will produce updated advice for health care professionals as necessary.

Reporting

Health care professionals are encouraged to report issues with this product to Medsafe. Please include in your report:

  • a description of the issue
  • the total number of affected tests
  • batch numbers
  • any other relevant information.

If you have questions about this monitoring communication, please email: devices@health.govt.nz

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